Q&A and Video: Dr. Frank Arko talks calcified EVAR and TEVAR access with the help of IVL

Frank Arko III, MD is the Chief of Vascular and Endovascular Surgery at Carolinas Medical Center, Sanger Heart and Vascular Institute in Charlotte, North Carolina, one of the busiest aortic repair centers in the world.  He is a global expert on aortic repair techniques and peripheral arterial disease. 


Dr. Arko was interviewed at VEITH 2019 and kindly shared his experience so far with Shockwave IVL, specifically his use of IVL to facilitate safe and simple delivery of EVAR and TEVAR grafts in calcified iliac arteries.  After his interview, he answered a few questions for The Catalyst to continue the conversation.  Watch his interview and read his Q&A below!




Question: Dr. Arko, what are the challenges associated with calcium when trying to deliver AAA and TAA devices?


Dr. Arko: There have been significant advancements in the design of abdominal and thoracic endografts in recent years, but these are still relatively large diameter devices.  Many of the patients who present to us with aortic disease also have significant peripheral arterial disease.  This commonly involves tight stenoses, significant tortuosity and/or severe calcium in the iliofemoral arteries that we want to deliver the sheath through.  The presence of these factors significantly increases the likelihood of serious vascular injury, which drive morbidity and even mortality associated with these procedures.  Ultimately, patient outcomes are maximized and costs are minimized when we can keep these procedures minimally invasive and uncomplicated.  Calcium makes those goals harder to achieve.



Question: What various alternative approaches have you employed in order to safely deliver those grafts?


Dr. Arko: There have been various techniques used over the years to deliver endografts when access has been highly calcified.  Traditionally, we would sew on a conduit and pass the delivery sheath through that in order to bypass the problematic access.  Conduits worked in order to deliver the graft, but have been associated with significantly higher complications and patient recovery time.  We’ve also used balloon dilatation or progressive mechanical dilators, which may sometimes help, but usually not when there is significant calcium present, particularly if that calcium is circumferential.  “Pave and crack” techniques could be considered - whereby we implant covered stents and aggressively post-dilate - but these techniques are time-consuming and often require multiple expensive stents.  Finally, we have used atherectomy devices in the iliac arteries, but they are typically not big enough to impact large vessel calcium, are expensive and carry a risk of serious complications, particularly distal embolization.



Question: What is the potential impact of Intravascular Lithotripsy on your treatment algorithm for aortic aneurysm patients with complicated iliofemoral access?


Dr. Arko: In our practice, upwards of 20% of patients require some form of adjunctive procedure to enable safe delivery of abdominal and thoracic endografts.  These cases take longer to perform, are often associated with patient morbidity, longer hospital length of stay and/or higher direct device cost.  In this context, IVL is an important option to consider for at least some subset of those patients in order to modify the challenging calcium, safely deliver the graft and them get them up and walking and out of the hospital as quickly as possible.  Generally speaking, it may be preferable to try IVL first before resorting to any other form of adjunctive procedure.





Important Safety Information


Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Indication for Use – The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries.  Not for use in the coronary or cerebral vasculature.


Contraindications – Do not use if unable to pass 0.014 guidewire across the lesion • Not intended for treatment of in-stent restenosis or in coronary, carotid, or cerebrovascular arteries.


Warnings – Only to be used by physicians who are familiar with interventional vascular procedures • Physicians must be trained prior to use of the device • Use the Generator in accordance with recommended settings as stated in the Operator’s Manual


Precautions – Use only the recommended balloon inflation medium • Appropriate anticoagulant therapy should be administered by the physician • Decision regarding use of distal protection should be made based on physician assessment of treatment lesion morphology


Adverse Effects – Possible adverse effects consistent with standard angioplasty include: • Access site complications • Allergy to contrast or blood thinners • Arterial bypass surgery • Bleeding complications • Death • Fracture of guidewire or device • Hypertension/Hypotension • Infection/sepsis • Placement of a stent • Renal failure • Shock/pulmonary edema • Target vessel stenosis or occlusion • Vascular complications. Risks unique to the device and its use: • Allergy to catheter material(s) • Device malfunction or failure • Excess heat at target site


Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions, and adverse events. www.shockwavemedical.com


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